Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.

Heart Failure Clinical Trial

— HIS-alt_2  

Official title:

Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With Symptomatic Heart Failure Despite Optimal Medical Treatment and an ECG With a Typical Left Bundle Branch Block Pattern.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409119
• Other study ID #: HIS alternative 2
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: Berit Th Philbert, MD PhD
• Phone: +4535451410
• Email: berit.thornvig.philbert[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.

Description:

Biventricular pacing has for more than a decade been standard of care for patients with HFrEF, LVEF < 35%, NYHA II-IV despite optimal medical treatment and an ECG with left bundle branch block (LBBB). However, it is not always ideal because of several drawbacks such as phrenic nerve capture, inability to reach late activated areas and many more. Direct HIS pacing can in many cases capture the left bundle and provide normal electrical activation of the left ventricle but sometimes with high pacing thresholds. Recently direct left bundle branch pacing has shown promise with synchronous activation of the left ventricle at low pacing thresholds.

In the present study we randomize 125 patients in one center to either conventional CRT (45 patients) or HIS/LBB pacing (80 patients). In the HIS/LBB arm, direct HIS-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is > 2.5 V at 1 ms we switch to placing a LBB-lead.

Power calculation for non-inferiority: With the 50 patients in the first His Alternative study (25 Biv-CRT og 25 His-CRT) we observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. Using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with LVEF = 35% assessed by echocardiography, NYHA class II-IV heart failure symptoms despite optimal medical treatment and

• Either planned new implantation of a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block (see definition below)

• Or planned upgrade of an existing pacemaker or ICD to a biventricular pacing system (CRT-P or CRT-D), where the ECG is with sinus rhythm and a typical left bundle branch block or there has been> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment

• Signed informed consent

Typical left bundle branch block:

QRS width > 130 msec for women and > 140 msec for men QS or rS pattern in leads V1 and V2, and mid-QRS plateau phase with or without extras in at least 2 of leads V1, V2, V5, V6, I, and aVL

Exclusion Criteria:

• Existing biventricular pacing system

• Permanent atrial fibrillation

• Severe renal failure with eGFR < 30 ml/min

• AMI or CABG within the last three months

• The patient does not want to participate

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Block
• Heart Failure
• Left Bundle-Branch Block

Intervention

Device:
• HIS/LBB pacing
3830 lead to HIS or LBB
• LV pacing
LV lead in a CS branch

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Left ventricular end-systolic volume	Echocardiographic response after 6 months defined as decrease in left ventricular systolic volume of = 15% of baseline	6 months
Primary	Success rate of implanting a HIS-bundle lead with capture of the left bundle branch or a LBB-lead with narrowing of QRS	The success rate of implanting a pacing lead to the HIS-bundle with capture of the left bundle at a threshold < 2.5 V at 1 ms or implantation of a LBB lead with narrowing of the QRS duration and maintaining this effect at 6 month follow-up	6 months
Secondary	Change in LVEF and left ventricular chamber dimensions	Echocardiographic response assessed by chamber dimensions and LVEF on a continuous scale	6 months
Secondary	Change in 6-min hall-walk test	Functional response after 6 months defined as an increase in 6-min walking distance of = 20% of the initial value	6 months
Secondary	Change in NYHA class	Symptomatic response after 6 months defined as a fall in NYHA class of = 1	6 months
Secondary	Change in Minnesota Living with Heart Failure score	Change in well-being after 6 months defined as a decrease in Minnesota Living With Heart Failure score of = 15% of baseline	6 months
Secondary	Shortening of QRS duration	Shortening the duration of the QRS complex defined as the widest paced QRS complex rated at 12-lead ECG after 6 months	6 months
Secondary	Change in NT-pro BNP value	Change in NT-pro BNP value	6 months
Secondary	Complications	Device-related complications (periprocedural: electrode reoperation, pneumothorax, hemothorax, pericardial bleeding/tamponade and later (after 30 days post implantation): LV/HIS electrode reoperation, change of device due to battery depletion and infection requiring extraction).	6 months